Flumazenil for the Treatment of Primary Hypersomnia

This study has been completed.

Sponsor:

Lynn Marie Trotti

ClinicalTrials.gov Identifier:

NCT01183312

First Posted: August 17, 2010

Last Update Posted: December 6, 2013

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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Participants were recruited from the Sleep Center of the Emory Clinic, in Atlanta, GA, USA, between December 2010 and October 2011.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

12 patients were enrolled; of these, 2 were excluded prior to randomization because screening laboratory test results were abnormal.

Reporting Groups

Description

Placebo First, Then Flumazenil

Placebo administered sublingually three times during the first study day, followed by a washout of at least 7 days, then flumazenil administered sublingually three times during the second study day.

Flumazenil First, Then Placebo

Flumazenil administered sublingually three times during the first study day (as 12 mg, then 6 mg, then 6 mg, at approximately 3 hour intervals), followed by a washout of at least 7 days, then placebo administered sublingually three times on the second study day.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Placebo First, Then Flumazenil

Placebo during the first intervention day and sublingual flumazenil during the second intervention day (after washout period).

Flumazenil First, Then Placebo

Sublingual flumazenil during the first intervention day and placebo during the second intervention day (after washout period).

A PVT lapse is defined as a reaction time exceeding 500 msec following the presentation of a single stimulus, which are then summed for the entire 10 minute PVT testing period. The measure used was the change in the frequency of lapses from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).

Time Frame

10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Intention to treat (all randomized subjects were included)

Reporting Groups

Description

Placebo

Sublingual placebo administered three times over a single day, in either first or second intervention period

Sublingual Flumazenil

Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period

PVT Additional Measure #5, Change in Visual Analog Scale Rating of Sleepiness at the Completion of PVT [ Time Frame: 10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject) ]

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

EEG power was specified as a secondary outcome measure. Second-by-second manual artifact removal has been necessary to ensure interpretable data. This artifact removal is in progress and results will be reported separately.